Is Eastern Europe Missing Out?

A new, long-acting injectable to prevent HIV infection could be a “game-changer” in ending the AIDS epidemic, if all who would benefit can access it.

In the phase 3, double-blind, randomized, controlled trial PURPOSE 1, 100% of 2134 women aged 16-25 years in South Africa and Uganda who received a twice yearly injection of the drug lenacapavir were protected against HIV. On the other hand, there were 39 infections among the 2136 participants who received daily oral emtricitabine-tenofovir alafenamide and 16 infections among the 1068 who received daily oral emtricitabine–tenofovir disoproxil fumarate (active control).

In the PURPOSE 2 trial, lenacapavir offered almost complete protection to cisgender men, transgender women, transgender men, and gender nonbinary individuals who have sex with partners assigned male at birth in Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the United States.

Lenacapavir is already approved as a treatment for HIV in the United States, sold for US$42,250 per patient per year under the name Sunlenca. The twice-yearly injection is an alternative to oral preexposure prophylaxis (PrEP), a daily pill, which many struggle to access and take every day.

In October, lenacapavir manufacturer, Gilead, announced a deal that allows six manufacturers to produce generic versions of the drug in 120 low- and middle-income countries that are “high-incidence, resource-limited.” 

However, experts have expressed concern that the deal leaves out most middle- and high-income countries, including several countries in Eastern Europe and Central Asia, the Middle East and North Africa, and most of Latin America.

Forty-one percent of new infections are in upper-middle income countries. This will ultimately widen the gap in access to care and possibly delay the end of the AIDS epidemic.

“These are the regions where HIV is growing the fastest,” Andrew Hill, MD, PhD, senior visiting fellow in the Department of Pharmacology and Therapeutics at the University of Liverpool, Liverpool, England, told Medscape Medical News. His research found that lenacapavir could be manufactured for less than $100 per patient per year — more than 400 times less than its current cost.

“Gilead’s restrictions on access to lenacapavir could allow the HIV epidemic to spread. This is the closest we have ever been to an HIV vaccine, but it will be very hard for people at risk of HIV to access lenacapavir at affordable prices in many countries where HIV is spreading the fastest,” he said.

New Infections Rising

A 2024 UNAIDS report, titled The Urgency of Now: AIDS at a Crossroads, found that the number of new HIV infections in Eastern Europe and Central Asia increased by 20% between 2010 and 2023 to 140,000, and deaths increased by 34% to 44,000. 

While the war in Ukraine has partly been attributed to the rise, widespread unsafe drug injecting practices are a key factor in the region’s epidemic, representing 27% of new infections, according to UNAIDS.

Moreover, in 2022, the number of gay men and other men who have sex with men who acquired HIV was 144% higher than in 2010 in the Eastern Europe and Central Asia (EECA) region. Of the 2.1 million people living with HIV in the region, only 59% are aware of their status and 50% are on treatment.

The region’s key populations continue to face human rights violations, stigma, and discrimination and punitive laws and policies that prevent access to critical HIV services.

Eleven countries in the EECA region have been included in Gilead’s deal, but none have been included on the priority list of 18 countries that will be provided Gilead-supplied products until manufacturers are up and running. In addition, several countries with high HIV incidence among key population groups, including Russia, Serbia, and Bulgaria, have been excluded. Every year, Russia records more than 50,000 new HIV infections.

Moreover, new data from the WHO found that, in 2023, several European countries, including Ireland, Iceland, Finland, Malta, and Montenegro, reported their highest number of HIV diagnoses in a single year over the past decade. Most Western and Northern European countries are not included in the deal.

Is Political Will Lacking? 

“The region is still notably affected by HIV transmission, with new diagnoses in many countries rising,” President-Elect of the European AIDS Clinical Society, Professor Miłosz Parczewski, MD, PhD, told Medscape Medical News.

“One of the main reasons the EECA region is being left behind is political stigma, which I define as a lack of political will and full engagement in the HIV response, mostly due to the inadequate perception that the epidemic is limited to the LGBTQI community who are still persecuted in some countries, lack of public awareness, economic hardship, and migration.” 

Parczewski said there is “an urgent need” to expand prevention programs, including the availability of PrEP.

“The expansion of PrEP may be pivotal in ending the HIV epidemic in the region,” he added.

Whether this happens remains to be seen. Globally, oral PrEP access is limited. In 2023, only 3.5 million people were using oral PrEP, against the 2025 target of 21.2 million people. Prevention services across the region are limited or not formally implemented due to financial barriers to access, cost, and stigma and discrimination.

The Funding Challenge

Debra ten Brink, MD, MPH, from the Optima Consortium for Decision Science within the Burnet Institute, Melbourne, Australia, whose work supports cost-effective decision-making in global health, said the region faces a dual funding challenge.

“Domestic funding may be constrained by competing government priorities, while many EECA countries are classified as upper-middle or high-income, restricting their eligibility for international funding,” she told Medscape Medical News. “This dual challenge results in a pronounced funding gap in the region.” 

For the countries who are unable to purchase generic lenacapavir and don’t qualify for Global Fund aid, they will have the option to pay full price for the drug, which Gilead is yet to price for prevention, or some may go down the path of issuing a compulsory license, which overrides intellectual property protections. The issue highlights the dilemma of determining access to medicines and pricing based on economic status rather than public health need.

Andriy Klepikov, PhD, executive director of the Alliance for Public Health, one of the largest HIV-focused NGOs in Ukraine and the wider region, told Medscape Medical News he was relieved that Ukraine was included in the deal.

“Of course, we should be aiming for equal access for everyone everywhere but, from another side, we should start somewhere with something,” he said. “Lenacapavir is a game-changing medication. In my country, Ukraine, it is critically needed, and we are awaiting its availability.” 

Andrew Hill has disclosed no relevant financial relationships.

Andriy Klepikov disclosed that the Alliance for Public Health receives funding from The Global Fund to Fight AIDS, Tuberculosis and Malaria; the US Centers for Disease Control and Prevention; and other donors.

Debra ten Brink has received research funding from The Global Fund to Fight AIDS, Tuberculosis and Malaria.

Sophie Cousins is a global health journalist currently in South-East Asia.